13. Do I Have to Register my Human Research on clinicaltrials.gov?

Organizations or clinical investigators with primary responsibility for initiating and conducting clinical trials may submit trial data to ClinicalTrials.gov using the Protocol Registration System (PRS). A trial must be approved by a human subject review board and must conform to the regulations of the appropriate national health authorities, in order to be registered.

Investigators or sponsors for trials which have been registered with ClinicalTrials.gov by another individual or organization should contact that data provider directly with any questions or concerns regarding the information posted on ClinicalTrials.gov.

U.S. Public Law 110-85 (FDAAA)The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices.

Multi-site trials and multi-sponsor trials are susceptible to duplicate registration, thus care must be taken in how the trials are registered. For multi-sponsor trials it is the lead sponsor who should take responsibility for registration. It is critical that investigators and sponsors work together to ensure that a trial is registered once and only once.

Account Application Process

Organizations and investigators wishing to register trials must first apply for a PRS account via the links provided below. Within two business days, ClinicalTrials.gov will create the account and send email with instructions on how to login to the PRS, so that you can register your trials.

If you already have an account but have forgotten the password or other information required to login, use the "Forgot password" link on the PRS login page on the web at register.clinicaltrials.govQuestions? Contact us at register@clinicaltrials.gov